Clinical trial of dual immunotherapy agents for melanoma brain metastase
The study by Tawbi et al. published in the New England Journal of Medicine in late August examines the effects of dual-agent immunotherapy on intracranial metastatic disease. This open-label Phase II trial uses nivolumab and ipilimumab to treat patients with metastatic melanoma with at least one previously untreated intracranial metastasis. The two drugs were combined initially and then nivolumab was used for maintenance for up to 2 years. Overall, 101 patients were treated in the study, and 94 were evaluated for primary endpoint intracranial clinical benefit (stable disease or better). At a median follow up of 14 months, 57% of patients had intracranial clinical benefit, with the 56% having extracranial benefit. Median survival and progression free survivals were not reached and the 6-month intracranial progression free survival and overall survival were 64% and 92%, respectively. This study represents a major step forward in systemic therapy for intracranial disease.